Events

CABLES-ELETRODOS SPRINT FIDELIS - MEDTRONIC. MODELS: 6930, 6931, 6948 and 6949. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medtronic Inc.; Medtronic Comercial Ltda 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    886
  • 날짜
    2007-10-16
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    The Medtronic Ltda. Has already received a communication from Medtronic Ltda informing the product collection action in Brazil. #### Update (29/02/2008): Medtronic Ltda has already sent to Medtronic Inc (Minneapolis - USA) all Sprint Fidelis cables collected in Brazil. In total, 471 cables were collected and shipped. #### Update (05/08/2011): Medtronic is informing its customers by means of an alert message that, in the event of a fracture in a Fidelis stimulation conductor , the company recommends implanting a new high-voltage electrode cable, with or without withdrawal of the fractured Fidelis Electrode Cable. Implantation of a stimulation lead is no longer an option recommended by the company, while maintaining the use of Fidelis High Voltage Conductors after a fracture in a Fidelis stimulation conductor.
  • 원인
    The company medtronic is suspending the distribution of the electrode cables of the sprint fidelis line, used in implanted defibrillators. according to the company, there is a possibility of cable-electrode fracture after its implantation.
  • 조치
    Immediately stop using the Sprint-Fidelis Model 6930, 6931, 6948, and 6949 electrode cables for further implantation of defibrillators. The company Medtronic Inc also reported that those patients who have implanted electrode cables (of the models above) should seek their doctors for guidance. Medtronic recommends the following actions as an integral part of routine patient monitoring: Reduce the risk of detection and inappropriate therapies (motivated by oversensing) by scheduling VF detection by adjusting the initial Number of Intervals to be Detected (NID) for nominal (18/24) or higher, as physician assessment and re-detection NID for nominal parameters (12/16). Turn ON Patient Alert ™ for RV Pacing, RV Defibrillation, and VCS defibrillation impedances. To optimize the efficacy of electrode impedance alert, the recommendation is as follows: 1) Review the electrode V pacing behavior curve to calculate the patient's usual chronic impedance value (the usual Fidelis electrode values ​​should be between 350-1000 ohms). 2) Maximum electrode impedance alert threshold for 1000 ohm RV stimulation in case the patient's normal chronic impedance is less than or equal to 700 ohms or 3) Maximum electrode impedance alert threshold for RV 1500 stimulation ohms, in case the patient's normal chronic impedance is greater than or equal to 700 ohms. 4) Maximum limit of the electrode impedance alert for RV and 100 ohm VCS defibrillation. It is estimated that the aforementioned patient treatment recommendations increase the likelihood that the lead wire fracture will be detected by the Patient Alert and reduce the possibility of administering inappropriate therapies. According to the review of the available data, a more frequent follow-up does not seem to bring an additional benefit.

Device

CABLES-ELETRODOS SPRINT FIDELIS - MEDTRONIC. MODELS: 6930, 6931, 6948 and 6949.

Manufacturer

Medtronic Inc.; Medtronic Comercial Ltda
  • Source
    ANVSANVISA